A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy

The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in subjects with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.

A Randomized, Controlled, Multicenter, Open Label Study With Blinded Assessment of the Efficacy of the Humanized Anti-IL 23p19 Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy

Percentage of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 24 [ Time Frame: Week 24 ]

Denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

Secondary Outcome Measures:

Percentage of participants with a PASI 50 response [ Time Frame: Up to 24 weeks ]

Denotes greater than or equal to 50% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

Percentage of participants with a PASI 75 response [ Time Frame: Up to 24 weeks ]

Denotes greater than or equal to 75% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

Percentage of participants with a PASI 90 response [ Time Frame: Up to 24 weeks ]

Denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

Percentage of participants with a PASI 100 response [ Time Frame: Up to 24 weeks ]

Denotes greater than or equal to 100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

Change from Baseline in PASI [ Time Frame: Up to 24 weeks ]

PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

Change from Baseline in Body Surface Area (BSA) affected by psoriasis [ Time Frame: Up to 24 weeks ]

Change from Baseline in Psoriasis Symptom Scale (PSS) [ Time Frame: Up to 24 weeks ]

The PSS is a four-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis.

Percentage of participants with PSS of 0 (none) [ Time Frame: Up to 24 weeks ]

The PSS is a four-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis. Scores range from 0 (none) to 4 (very severe).

Change from Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Up to 24 weeks ]

The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject’s quality of life, overall health, and disability status.

Percentage of participants with DLQI scores of 0 (not relevant/not at all) or 1 (a little) [ Time Frame: Up to 24 weeks ]

The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject’s quality of life, overall health, and disability status. Scores range from 0 (not relevant/not at all) to 3 (very much).